Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
ATL-962/175/CL, orlistat
Study information
Scientific title
Acronym
Study hypothesis
Does ATL-962 induce weight loss in diabetic patients and is its safety and tolerability profile superior to that of orlistat in such patients?
Ethics approval
Not provided at time of registration
Study design
Randomised three arm placebo controlled parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Obesity in patients with Type II diabetes
Intervention
ATL-962 (40 mg, 80 mg, or 120 mg), or placebo, or orlistat (120 mg) three times a day for 12 weeks
Intervention type
Drug
Phase
Not Specified
Drug names
ATL-962 (cetilistat), orlistat, metformin
Primary outcome measure
Absolute weight loss compared to baseline
Secondary outcome measures
Proportion of patients achieving 5% or 10% weight loss; changes in waist circumference; changes in lipid profiles; changes in markers of diabetes; incidence of GI adverse events; changes in other safety parameters
Overall trial start date
01/12/2004
Overall trial end date
30/06/2005
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Type II diabetic patients
2. Aged 18-65
3. Body Mass Index (BMI) between 28 kg/m2 and 45 kg/m2
4. Glycosylated haemaglobin (HbA1c) value between 6% and 10%
5. Being treated with a stable dose of metformin
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
600 patients randomised
Participant exclusion criteria
1. Significant weight loss in the previous 3 months
2. Weight gain during the run-in period
3. Other serious systemic disease, except for controlled hypertension, mild asthma, and primary hypothyroidism
4. History of GI disorders
5. Previous surgery for weight loss
Recruitment start date
01/12/2004
Recruitment end date
30/06/2005
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Barts and The London
London
E1 2AA
United Kingdom
Sponsor information
Organisation
Alizyme (UK)
Sponsor details
Granta Park
Great Abington
Cambridge
CB1 6GX
United Kingdom
+44 (0)1223 896 000
Medical.Information@alizyme.co.uk
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Alizyme (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19461584
Publication citations
-
Results
Kopelman P, Groot Gde H, Rissanen A, Rossner S, Toubro S, Palmer R, Hallam R, Bryson A, Hickling RI, Weight loss, HbA1c reduction, and tolerability of cetilistat in a randomized, placebo-controlled phase 2 trial in obese diabetics: comparison with orlistat (Xenical)., Obesity (Silver Spring), 2010, 18, 1, 108-115, doi: 10.1038/oby.2009.155.